New Bill To Require Supplement Registration

A bill reintroduced by Senators Dick Durbin, D-Il and Richard Blumenthal, D-CT to require registration of all dietary supplements with FDA is a solution in search of a problem, according to trade organizations.

The act, called the Dietary Supplements Labeling Act, has been introduced by the two senators before. The present version seems indentical to those previous go rounds, accordoing to Michael McGuffin, executive director of the American Herbal Products Association and is identical in its intent. In his view, “registration” is tantamount to “premarket approval.”

“I think it’s no secret what Dick Durbin thinks is appropriate for this class of goods. It’s premarket approval,” McGuffin told NutraIngredients-USA. “He’d like the FDA to be able to say you may or may not sell that product.”

Labeling requirements

Durbin’s bill would also amend certain labeling requirements. In particular, it would require lot numbers on all supplement labels, something many companies are already doing though they are not required to do so under law, McGuffin said.

“The fact that this bill would require ever dietary supplement to have a lot number on it, they almost all do already. The normal industry practice to put a lot number on labels,” he said. “There isn’t a real good reason to pass a law requiring us to do something that we already do.”

Steve Mister, president and CEO of the Council for Responsible Nutrition, said his group opposes the proposed law because it would do nothing to better protect public safety.

“We oppose the Dietary Supplement Labeling Act of 2013 because it creates added burdens for both FDA and companies already following the law, but does not address the problem of those companies that are disregarding the law. Without robust enforcement, companies who look for loopholes and disregard their legal obligations will continue to ignore new requirements,” Mister said.

Rather than nipping at the edges of the issue, Congress should drive right to the heart and give FDA enough funding to fully enforce the laws already on the books, Mister said.

“Rather than creating new laws, our industry needs a renewed commitment from Congress to provide FDA with additional funding and resources so the agency can use the ample enforcement tools already at its disposal to take aim at companies that do not comply with the regulations currently in place,” he said.

Loren Israelsen, president of the United Natural Products Alliance concurred, saying: "As drafted (the bill) would not solve the problems it seeks to address. In fact, it would likely impede progress on cracking down on unlawful operators by adding a series of unfunded mandates to an already underfunded FDA dietary supplement enforcement effort."

Safety questions

McGuffin said Durbin had called into question the safety of dietary supplements, and implied that situation was worsening.

“His press release was focused on a lot on the significant increase of adverse event reports as the reason that this law is needed. He knows as I know and as his staff knows that an adverse event is not evidence of harm. It is only evidence that a company received a call that there is a temporal association between the use of a product and an adverse experience,” he said.

To address this concern, Durbin’s bill would call for warning labels on supplements connected to the reports of adverse events. This is a nonstarter, as far as Mister is concerned.

“We cannot support legislation that directs FDA to require warning labels for products or ingredients that ‘could cause’ adverse events or potential risks as this is a case of the precautionary principle run amok. While the premise may be well intentioned, in practice this requirement would lead to confusing and unnecessary label instructions likely to deter consumers from using beneficial dietary supplements based on uncommon or minuscule risks,” Mister said.

Communicate through constituents

As far as the bill’s chance of passage, McGuffin was unwilling to speculate. But he said AHPA will pursue a similar strategy to what it has employed before, and that is encourage members to communicate with their elected representatives and to reiterate a message they’ve delivered before.

“Sen. Durbin is a very smart lawmaker. He is in a position of some significant authority in the Democratic Party. We certainly can’t dismiss it. We will maintain our attention and vigilance. More than anything we will work with the constituents of Senators.

“We’ve got a law (DSHEA) that works. We’ve got a well-regulated class of goods,” McGuffin said.

Why do people keep voting for these guys?!!! Thank God for Rand Paul, he stands up for supplement freedom from what I understand. It seem the D's are always coming up with these bills and pressuring the R's to "Meet them half way" and these old, wrinkly guys just sign them without knowing what the bills are.
Any thoughts out there? Is there like, a petition we can all sign? Do we write a letter to someone?
I only buy reputable brands that have been around a wile so I would think the market is self regulating. That's why we have forums like this one, so we know what's good and what's not.The crappy brands just go out of business.

Why do people keep voting for these guys?!!! Thank God for Rand Paul, he stands up for supplement freedom from what I understand. It seem the D's are always coming up with these bills and pressuring the R's to "Meet them half way" and these old, wrinkly guys just sign them without knowing what the bills are.
Any thoughts out there? Is there like, a petition we can all sign? Do we write a letter to someone?
I only buy reputable brands that have been around a wile so I would think the market is self regulating. That's why we have forums like this one, so we know what's good and what's not.The crappy brands just go out of business.

Please contact your Senators. Use the following statement:

I am writing you over my concern about the new bill recently introduced: Dietary Supplements Labeling Act. I find this bill troubling in many regards and redundant. The bills main points are already being used by the Dietary Supplement Industry, such as lot numbers on bottles and the allowance of certain ingredients. The Certified Good Manufacturing requirements in place and the DSHEA Act as well as the NDI(New Dietary Ingredient) requirements already thoroughly regulate the industry. Is the industry perfect, of course not as no industry is. The new legislation would put needless red tape in place and bog down an industry that despite the recession has been steadily growing. In these troubling economic times I feel the last thing we need is to stifle growth of one of the few strong home grown job supplying industries. I thank you for your time as I know you are a very busy person. Have a great day.

I am writing you over my concern about the new bill recently introduced: Dietary Supplements Labeling Act. I find this bill troubling in many regards and redundant. The bills main points are already being used by the Dietary Supplement Industry, such as lot numbers on bottles and the allowance of certain ingredients. The Certified Good Manufacturing requirements in place and the DSHEA Act as well as the NDI(New Dietary Ingredient) requirements already thoroughly regulate the industry. Is the industry perfect, of course not as no industry is. The new legislation would put needless red tape in place and bog down an industry that despite the recession has been steadily growing. In these troubling economic times I feel the last thing we need is to stifle growth of one of the few strong home grown job supplying industries. I thank you for your time as I know you are a very busy person. Have a great day.

This is really an attempt to stop steroid production in the supplement industry though since companies are creating new ones every day and sticking enough supplemental ingredients in there with them to call it a "supplement". Either way, the manufacturers are only responding to demand. I say let consumers choose whether or not they want to take a risk with a prohormone..just like they often choose to take the risks associated with smoking and drinking. I see hypocrisy left and right when it comes to supplements, steroids and controlled substances. Non of the laws deter anyone from doing or taking what they desire.

It only pisses us off, really.

Plus, what will likely happen is that the supplement companies will make offers or perhaps % earnings to pay the FDA off and let them put stuff on the market anyways. At the end of the day, money is the only thing that talks in government regulation.

Registration means pre-approval of ingredients and dosages as for OTC drugs. It might grandfather ingredients but lock the combinations.

The largest class of FDA warnings are for herbal products with drug ingredients imported from the far east and sold over web or in oriental stores. They come from foreign-owned shell companies with minimal U.S. assets. FDA enforcement is like netting smoke.

Next are recreational drugs sold as "bath salts" that are also produced in small runs to be sold in head shops and convenience stores. There are no real companies behind the multitude of producers. FDA enforcement is like netting invisible smoke.

The FDA needs no additional authority against either but would never receive sufficient budget.

Durbin's bill would almost certainly ban steroidal products from main-stream supplement companies. Shell companies and non-companies would fill the vacuum with less dependable and less safe clones.

I cannot agree with the characterization of Rand Paul whose opposition relates to budget. Any claim that he "stands up for freedom" is denied by his position on contraception and abortion and his support for the "global gag rule" that prohibits talking about either. How is it ever good to "thank god" for our supposedly secular government?

Unfortunately we will never know the full story but I worked in politics for a few years. I guarantee money was passed down from Lobbyists somewhere. This law sounds like a watered down version of something else.

Everyone post this on their facebook and twitter along with the email and phone numbers of their state officials. These guys are getting ready for the upcoming elections, they will listen.

Please contact your Senators. Use the following statement:

I am writing you over my concern about the new bill recently introduced: Dietary Supplements Labeling Act. I find this bill troubling in many regards and redundant. The bills main points are already being used by the Dietary Supplement Industry, such as lot numbers on bottles and the allowance of certain ingredients. The Certified Good Manufacturing requirements in place and the DSHEA Act as well as the NDI requirements already thoroughly regulate the industry. Manufactures understand that producing safe and high quality products are the only road to success in this current market. This new legislation would put needlessly bog down an industry that despite the recession has been steadily growing. In these troubling economic times, the last thing we need is to stifle the growth of one of the few strong domestic job supplying industries. If this Act is past, it would cost thousands of American jobs state wide. I thank you for your time, your people are depending on you.

Registration means pre-approval of ingredients and dosages as for OTC drugs. It might grandfather ingredients but lock the combinations.

The largest class of FDA warnings are for herbal products with drug ingredients imported from the far east and sold over web or in oriental stores. They come from foreign-owned shell companies with minimal U.S. assets. FDA enforcement is like netting smoke.

Next are recreational drugs sold as "bath salts" that are also produced in small runs to be sold in head shops and convenience stores. There are no real companies behind the multitude of producers. FDA enforcement is like netting invisible smoke.

The FDA needs no additional authority against either but would never receive sufficient budget.

Durbin's bill would almost certainly ban steroidal products from main-stream supplement companies. Shell companies and non-companies would fill the vacuum with less dependable and less safe clones.

I cannot agree with the characterization of Rand Paul whose opposition relates to budget. Any claim that he "stands up for freedom" is denied by his position on contraception and abortion and his support for the "global gag rule" that prohibits talking about either. How is it ever good to "thank god" for our supposedly secular government?

I thought you were doing good until that last paragraph.

I resent the ignorance of the statement "Any claim that he "stands up for freedom" is denied by his position on contraception and abortion and his support for the "global gag rule" that prohibits talking about either". We could easily argue that aborted infants are having their freedoms stripped from them, too. So I wouldn't go there if I were you. It's an endless debate and at the end of the day you just either need to 1) stop caring about it or 2) have a heart change.

If you knew anything about our Constitution, you'd know that any one man cannot and will not ever amount to anything as far as legislative influence in our country. What I am saying is, you don't have to worry about the Paul's points of view on personal choices. That's what conservatives (all three parties) have been trying to tell all the other numbnuts for years! These petty issues like abortion and contraception are just ways to sidetrack the public from what they really need to focus on. They dont matter at all from a federal standpoint. Let states on local governments work those things out since populations within states and counties tend to share similar view points on morals. End of story.

The government is NOT in place to define morals. That is something every single person is born with. The Paul's understand that "globally gagging" the topic is not to gag private conversation about it but rather to shut the mouths of politicians from using the issue to side track the country! And another thing, do you really think that you're gonna find someone that you agree with on 100% of the issues? Just because you can't agree with him on a few things doesn't make him unworthy of following. Have some hope for Goodness sake.